Get expert insights into cough science, monitoring and research
As new mechanism-based therapies emerge and the field continues to refine its endpoint strategies, objective, continuous cough monitoring represents a strategic quantitative approach to complement existing outcome measures in bronchiectasis.
“CDRH clearance is neither necessary nor sufficient for CDER to accept a cough monitor as a trial endpoint. The two run on independent tracks.”
FDA device marketing approval and clinical trial endpoint acceptability are different issues. Equating the two may confuse sponsors about risks involved.
A decentralized feasibility study that delivered rich, real-world cough data without the scale, cost, or complexity of a trial or a market-research program.
About 50% of patients with refractory chronic cough go into full remission; they don’t have a chronic cough anymore. Over 80% experience a significant reduction in their symptoms.
“Despite the widespread use of cough-counting technologies, no system has yet received explicit FDA clearance for counting coughs.”
Over the last decade, several technologies have emerged that are capable of performing reliable cough monitoring in the real world. However, there remains a gap in regulatory clearance for devices explicitly designed to count coughs.
